Alimera again received bad news from the FDA on its application for approval of Iluvien. In a letter (a CRL or complete response letter), the FDA said that questions remained based on the data previously submitted, about the adverse reactions shown by …

Source: NICE
Area: News
The National Institute for Health and Clinical Excellence (NICE) has issued its Final Appraisal Determination (FAD) on ranibizumab for the treatment of diabetic macular oedema (DMO). Within the FAD, ranibizumab is not recommend…

NICE (National Institute for Clinical Excellence) in the UK has decided not to recommend Lucentis (ranibizumab) for diabetic macular edema (British spelling: oedema) treatment. NICE approves or turns down treatments that will be covered by the NHS (Nat…

Novartis AG, Europes second-largest drugmaker, failed to win approval from the U.K.s health-cost agency for its drug Lucentis in diabetics who suffer an eye condition. Lucentis wasnt cost effective in patients with macular edema, the National Institute…

Iluvien, a sustained release drug-delivery system for the treatment of diabetic macular edema, may be getting closer to possible FDA approval. The parent company, Alimera Sciences has resubmitted additional safety and efficacy data as requested by the FDA last year. …

Last July, I wrote a comprehensive report about Iluvien and the status and promise of other sustained release drug delivery systems (Iluvien and the Future of Ophthalmic Drug Delivery Systems). At that time, Alimera Sciences, the company developing Ilu…

At the AAO meeting in October, researchers reported that anti-VEGF drugs such as ranibizumab (Lucentis) and pegaptanib (Macugen) also appeared to be effective in improving visual acuity in patients with diabetic macular edema in a series of randomized, controlled trials. Full…

(Ophtalmology Times Europe) Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for its therapy Lucentis for the treatment of patients with diabetic macular oedema (DME). Full Story ->